FDA
Novartis drug PKC412 gets Breakthrough designation for AML
February 19, 2016Medical Communications, Research and Development FDA, Novartis, acute myeloid leukaemia
Novartis’ PKC412 (midostaurin) has become the latest in a sequence of FDA Breakthrough Therapy designations awarded this week- bagging the …
AZ’s durvalumab awarded breakthrough status in bladder cancer
February 18, 2016Research and Development AstraZeneca, FDA, bladder cancer
AstraZeneca, and its biologics/R&D arm MedImmune, have won FDA Breakthrough Therapy status for their bladder cancer drug durvalumab (MEDI4736), which …
Biosimilars: Can the US catch up in 2016?
February 12, 2016Medical Communications, Sales and Marketing Eli Lilly, Enbrel, FDA, Neulasta, Novartis, Pfizer, Sandoz, Zarxio, biosimilars
What are biosimilars? Biosimilars are essentially the biological equivalent of generic drugs to their branded small-molecule counterparts (what Ibuprofen is …
FDA advisory committee recommends approval of Remicade biosimilar
February 10, 2016Research and Development, Sales and Marketing FDA, Pfizer, Remicade, biosimilar, celltrion
An FDA advisory panel yesterday voted overwhelmingly in favour of approving CT-P13- Celltrion’s biosimilar version of Johnson&Johnson’s blockbuster arthritis drug …
Big pharma answers tough questions at US drug pricing hearing
February 5, 2016Medical Communications Drug pricing, FDA, Martin Shkreli, Senate, Turing Pharmaceuticals, US, Valeant, congress
Pharmaceutical industry executives came under intense scrutiny at a Congressional hearing in the US as the debate over the spiralling …
Lundbeck gets go-ahead for US and EU licence expansions
February 4, 2016Medical Communications, Sales and Marketing Abilify, EMA, FDA, Lundbeck, Otsuka, Takeda, aripiprazole, brintellix, vortioxetine
Lundbeck has earned two recommendations from regulatory committees of the FDA and the EMA, which both recommended the company’s drugs …
MSD gets FDA approval for hepatitis C drug Zepatier
January 29, 2016Medical Communications, Sales and Marketing FDA, MSD, Zepatier, hepatitis C
The competitive hepatitis C market is to get another contender, with FDA approving MSD’s new combo treatment Zepatier (elbasvir and …
FDA plans greater diversity in clinical trials
January 29, 2016Medical Communications, Research and Development FDA, Robert Califf, clinical trial, patient recruitment
The FDA is to focus on increasing patient diversity in clinical trials in 2016, to “ensure that research participants are …
AZ’s Lynparza gets prostate cancer breakthrough status
January 28, 2016Sales and Marketing AstraZeneca, Breakthrough Therapy Designation, FDA, lynparza, olaparib, prostate cancer
AstraZeneca’s Lynparza has been granted breakthrough therapy designation by the FDA as a monotherapy for the treatment of a specific …
FDA reviews Jardiance as cardiovascular diabetes treatment
January 27, 2016Research and Development, Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, jardiance
The FDA has accepted Boehringer Ingelheim and Eli Lilly’s supplemental New Drug Application for their diabetes drug Jardiance to be …
FDA to review Amgen’s Humira biosimilar
January 26, 2016Manufacturing and Production ABP-501, Amgen, FDA, biosimilar
The FDA has accepted for review Amgen’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to AbbVie’s Humira …
Shire tries again with lifitegrast dry eye FDA application
January 25, 2016Manufacturing and Production, Sales and Marketing FDA, Shire, dry eye disease, lifitegrast
Shire has resubmitted its New Drug Application (NDA) to the US FDA for its rejected dry eye syndrome drug lifitegrast. …
Patients sue J&J for $800m for ‘hiding antibiotic side effects’
January 22, 2016Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Janssen, Johnson and Johnson, Levaquin, Margaret Hamburg, lawsuit, levofloxacin
Six users of Johnson & Johnson’s antibiotic Levaquin are to sue the company for up to $870 million, claiming the …
FDA approves new Kyprolis combo for multiple myeloma
January 22, 2016Medical Communications, Sales and Marketing Amgen, FDA, Kyprolis, carfilzomib, multiple myeloma, myeloma
Amgen’s Kyprolis has been given another endorsement by the FDA as a multiple myeloma treatment – its second in six …
AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation
January 21, 2016Sales and Marketing AbbVie, Breakthrough Therapy Designation, FDA, Roche, venetoclax
AbbVie and Roche’s cancer drug venetoclax has been granted Breakthrough Therapy Designation by the FDA in combination with rituximab for …
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